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Evaluation of the Safety, Efficacy, Dose Response of the Bimatoprost Drug Ring System (BIM-DRS) in Pseudophakic Patients Diagnosed With Open Angle Glaucoma or Ocular Hypertension

NCT07641296 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-06-11

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if two different doses of the SpyGlass Bimatoprost-Drug Ring System (BIM-DRS) work to treat adult pseudophakic patients with either glaucoma or ocular hypertension. The main question it aims to answer is:

Does the BIM-DRS lower the pressure inside the eye to treat glaucoma or ocular hypertension?

Researchers will compare two different doses of the BIM-DRS implanted either with a pre-existing commercially available monofocal intraocular lens (IOL) or concurrently with the SpyGlass IOL (IOL with silicone pads (no drug)).

Participants will:

* Upon providing informed consent and successfully completing the screening visit, stop taking their IOP lowering medications in the eye to be treated.
* Complete a baseline visit to further evaluate eligibility in the study eye.
* Undergo surgery to implant the BIM-DRS (BIM-DRS and SpyGlass IOL for Cohorts 3 and 4). Only one eye of each participant will be treated.
* Complete post-operative follow-up visits for evaluation at Day 1, Week 2, Week 6, Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, and Month 36 (last study visit).

Conditions

Interventions

DRUG

BIM-DRS Low Dose

Bimatoprost-Drug Ring System Low Dose

DRUG

BIM-DRS High Dose

Bimatoprost-Drug Ring System High Dose

DEVICE

SpyGlass IOL with silicone pads (no drug)

SpyGlass Intraocular Lens with silicone pads (no drug)

Sponsors & Collaborators

  • SpyGlass Pharma, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2027-02-28
Completion
2030-03-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07641296 on ClinicalTrials.gov